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Sr. Director, Global Design Assurance

Company: Fox Rehabilitation
Location: Milpitas
Posted on: January 15, 2022

Job Description:

Do you want to make a meaningful difference in the quality of healthcare? Omnicell is empowering health systems and pharmacies to radically transform the way they manage medications, so they can achieve the vision of the Autonomous Pharmacy. Thousands of hospitals, pharmacies, skilled nursing facilities and care homes trust Omnicell to provide continuous innovation. They need us to deliver solutions to meet the ever-evolving challenges of the healthcare landscape. We encourage creative problem solving and outside-the-box thinking that only a diverse, well-rounded workforce can bring. Join us as we build on our powerful combination of advanced automation, predictive intelligence, and expert services to create a safer future for patients-one where medication errors are a thing of the past. You'll be joining an organization whose culture encourages individual development, rewards intellectual curiosity, and embraces an inclusive environment. Join our growing company and help shape the future at Omnicell! Senior Director, Global Quality Design Assurance Are you a Senior level quality design assurance leader who knows what it means to Do The Right Thing? Seeking an AMAZING role in Design Assurance? Omnicell has an exciting new role for you to join our EXTRAORDINARY Quality Team. The Senior Director, Global Quality Design Assurance will be responsible for leading a global team of inspired quality professionals responsible for pre and post market Quality Design Assurance and Product Regulatory activities. The role focuses on developing and leading the quality strategies to enable Omnicell product introductions and commercially released product support. While working with key leadership on regulatory strategies for enterprise and applications Cloud-based software integrated with on-prem medical devices, one will develop and maintain QMS processes to support SaMD and SaaS applications in alignment with the advancing initiatives of the FDA's Digital Health Center for Excellence. This Senior Director role provides leadership for ensuring quality practices are integrated within and across Omnicell's product development process. Through effective communication, problem solving and collaboration across multiple functions, this position will ensure the QMS processes are structured to drive exceptional experience for Omnicell Customers. Reporting to the Vice President of Global Quality and Product Regulatory, this position will manage the Product Design Assurance functions across Omnicell and be responsible for functional budgeting planning, talent development and collaboration with the senior leadership team to drive strategic plans. Responsibilities

  • Supports the establishment and continual improvement of QMS processes in direct support of Omnicell's design processes. -Plans, directs and implements all Quality Design Assurance activities for new and existing products including enterprise and applications Cloud-based software.
  • Forms strong partnerships -with Engineering, Product, and Manufacturing and provides effective support by devising long-term strategies that improve quality.
  • Leads the facilitation for the development of quality and product regulatory specifications and processes for new products.
  • Leads the Design Assurance team in the support of sanctioned projects. Provide quality and compliance direction, facilitation, coaching and mentoring for cross-functional personnel.
  • Provides an active role in design reviews to assess quality, compliance and business risk.
  • Direct the Defect Management process for pre and post market for all Omnicell products.
  • Manage the team to ensure Design outputs meet Design inputs including ensuring all products comply with the associate Product Regulatory Requirements.
  • Manage and ensure all product regulatory requirements are met for expansion into international markets as required to support business growth, including all CE Markings, product certifications are established and maintained.
  • Development and delivery of executive level presentations including the assessment of the effectiveness of the Omnicell Product Development processes.
  • FDA 510(k).
  • Define cyber security requirements.
  • Product registrations and establishments licensing. Required Knowledge and Skills
    • Proven record of accomplishment leading Global Design Assurance Teams.
    • Demonstrable knowledge of Quality in a high technology manufacturing and development environment (medical devices).
    • Familiar with software quality processes and tools required for high-quality software and systems release.
    • Specific training and demonstrated success in applying quality problem solving methods such as Software DFMEA, fishbone diagrams, process capability analysis, 8D methodologies, CAPA, DoE, SPC, etc.
    • Excellent written, presentation and interpersonal skills. Basic Qualifications
      • Minimum 10+ years of experience in a Leadership Quality role, ideally software design for medical products.
      • Minimum 5+ years of experience in product design and development.
      • Minimum 5+ years in managing technical teams.
      • Experience leading change in a matrix organization and integration of QMS.
      • Proven record of accomplishment and experience in ISO 9001 or ISO 13485 QMS environments.
      • Strong experience in leadership, planning, and project management. Preferred Qualifications
        • MBA
        • Software medical device experience in post-market activities Work Conditions
          • Travel - 20% domestic and international
          • This role can be located in Pittsburgh, St. Petersburg, Milpitas / Mt.View or Plano #LI-LS1 To protect our employees, partners, and customers, Omnicell requires most U.S. employees to either be fully vaccinated for COVID-19 or obtain approval from Omnicell for an exemption and accommodationfora medical condition or a sincerely-held religious belief or practice. Nothing in this job description restricts management's right to assign or reassign duties and responsibilities to this job at any time. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability. Omnicell will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, or (c) consistent with the contractor's legal duty to furnish information.

Keywords: Fox Rehabilitation, Milpitas , Sr. Director, Global Design Assurance, Executive , Milpitas, California

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